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VTE risk prediction scores for Deep Vein Thrombosis

Q: Are persons aged 30 or above accepted as participants in this medical experiment?

According to the requirements for participation, patients who are between 0 and 21 years old can enrol in this clinical trial.

Q: Are new participants being recruited for this experiment?

The clinicaltrials.gov portal reveals that this trial has already completed its recruitment process, which began on November 2nd 2020 and ended with the last update on November 17th 2022. However, 287 other trials are still actively recruiting patients at present.

Q: Who is eligible to engage in this clinical experiment?

This trial seeks 15000 paediatric individuals between infancy and 21 years. For eligibility, patients must meet the following conditions: admission to an inpatient unit at Monroe Carell Jr. Children's Hospital at Vanderbilt.

N/A

Waitlist Available

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial will test a new way to predict which children in the hospital are at risk for developing blood clots. Using this information, doctors may be able to screen more high-risk patients and reduce the number of children who develop blood clots.

Eligible Conditions

Deep Vein Thrombosis
Pulmonary Embolism
Pediatrics

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of VTE Events

Secondary outcome measures

Total Number of Bleeding Events

Total Number of High-Risk Patients Started on Anticoagulation

Total Number of Patients Started On Anticoagulation If It Was Recommended

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: VTE risk prediction scoresExperimental Treatment1 Intervention

Patients in the intervention arm will have their VTE risk prediction scores presented to the study team daily on weekdays via an automated report, which will list patients in descending order of risk severity for review by the VTE research team each weekday. Starting with the highest risk patients, the VTE research team will review each patient and clinical situation, and then the VTE research team will directly discuss risks/benefits of prophylactic anticoagulation with the admitting team. Patients with a risk score <2.5% will not be reviewed, and the investigators anticipate most of the intervention arm patients will fall into this category (based on our previous data, the investigators anticipate >90% of all patients will score <2.5%). The VTE risk report will be re-calculated based on updated EHR data every day at midnight.

Group II: Standard of careActive Control1 Intervention

Patients randomized to the control arm will continue to receive current standard of care anticoagulation practice, which is at the discretion of the admitting team. In general, nearly no pediatric patients are offered prophylactic anticoagulation unless a previous VTE has been identified. This currently is at the discretion of the provider and no risk scoring is used. VTE risk prediction scores will be calculated and stored for analysis, these will not be visible to the study team in real time.

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Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

857 Previous Clinical Trials

654,766 Total Patients Enrolled

Allison P Wheeler, MDStudy DirectorVanderbilt University Medical Center

Buddy Creech, MDStudy ChairVanderbilt University Medical Center

Media Library

VTE risk prediction scores Clinical Trial Eligibility Overview. Trial Name: NCT04574895 — N/A

Deep Vein Thrombosis Research Study Groups: Standard of care, VTE risk prediction scores

Deep Vein Thrombosis Clinical Trial 2023: VTE risk prediction scores Highlights & Side Effects. Trial Name: NCT04574895 — N/A

VTE risk prediction scores 2023 Treatment Timeline for Medical Study. Trial Name: NCT04574895 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are persons aged 30 or above accepted as participants in this medical experiment?

"According to the requirements for participation, patients who are between 0 and 21 years old can enrol in this clinical trial."

Answered by AI

Are new participants being recruited for this experiment?

"The clinicaltrials.gov portal reveals that this trial has already completed its recruitment process, which began on November 2nd 2020 and ended with the last update on November 17th 2022. However, 287 other trials are still actively recruiting patients at present."

Answered by AI

Who is eligible to engage in this clinical experiment?

"This trial seeks 15000 paediatric individuals between infancy and 21 years. For eligibility, patients must meet the following conditions: admission to an inpatient unit at Monroe Carell Jr. Children's Hospital at Vanderbilt."

Answered by AI

Recent research and studies

PediatricsJournal

A Real-time Risk-prediction Model for Pediatric Venous Thromboembolic Events

Walker, Shannon C., C. Buddy Creech, Henry J. Domenico, Benjamin French, Daniel W. Byrne, and Allison P. Wheeler. 2021. “A Real-time Risk-prediction Model for Pediatric Venous Thromboembolic Events”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2020-042325.

clinicaltrials.govStudy

Using a Real-Time Risk Prediction Model to Predict Pediatric Venous Thromboembolism (VTE) Events

Shannon Walker 2020. "Using a Real-Time Risk Prediction Model to Predict Pediatric Venous Thromboembolism (VTE) Events". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04574895.